Older AdultNCT06825130
High-intensity Interval Training Combined with Muscle-strength Training in Older Women
A study testing Exercise in people with Older Adult, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
Women generally live longer than men but often experience a faster muscle mass loss due to inactivity, which can lead to weakness and disability. Despite these risks, women, particularly older women, are less active than men. Read more about this study
- Who is it for?
- Ages 60 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Older Adult
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Females (biologically at birth)
- At least 60 years of age at the time of signing the informed consent
- Non-smoker, including electronic cigarettes
- Not participating in routine high-intensity aerobic or muscle strength exercise training (≥ 75 min/week of structured vigorous aerobic exercise, or 2 times /week of structured muscle strength training)
- Able to perform a cardiopulmonary exercise testing (CPET) to exhaustion
- willing to complete baseline and follow-up measures, and attend prescribed exercise sessions at the University of Nottingham
- willing and able to give informed consent for participation in the study
Who cannot join
- Diagnosed with cardiovascular disease, kidney disease, diabetes, obstructive pulmonary disease, or uncontrolled hypertension
- History or current neurological or psychiatric illness, or motor or cognitive restrictions
- Contraindications to symptom-limited cardiopulmonary exercise testing (CPET), including resting hypertension with systolic blood pressure >200 mmHg or diastolic blood pressure > 110 mmHg, uncorrected medical conditions, such as significant anemia, important electrolyte imbalance, and hyperthyroidism, mental impairment with limited ability to cooperate, physical disability that precludes safe and adequate testing.
- Having taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
David Greenfield Humnn Physiology Unit (DGHPU), University of Nottingham
Nottingham, Nottingham, NG72UH
Tasuku Terada, PhD, tasuku.terada@nottingham.ac.uk
About this study
Official title: Feasibility and Preliminary Efficacy of High-intensity Interval Training Combined with Muscle-strength Training in Older Women: Pilot Randomized Controlled Trial
Women generally live longer than men but often experience a faster muscle mass loss due to inactivity, which can lead to weakness and disability. Despite these risks, women, particularly older women, are less active than men. In England, less than one-third of women engage in sufficient aerobic activity, and less than 5% do enough muscle strength training. Common reasons for not exercising include lack of time and enjoyment.
High-intensity interval training (HIIT) is an efficient and effective way to exercise that many women find more enjoyable than longer workouts. HIIT has been shown to be effective in older women, helping them improve their fitness with less time commitment. Because HIIT is time-efficient, it can be combined with muscle strength training without significantly increasing the duration of the exercise session, which may lead to even better fitness results.
This study will assess how practical it is for older women to do HIIT and strength exercise combined training. It will also investigate whether this combined approach can improve overall fitness, muscle strength, aerobic fitness, and quality of life more than HIIT alone.
- Conditions
- Older Adult
- Being tested
- Exercise
- Keywords
- Women, HIIT, Resistance exercise, Combined exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Participants will attend 30-min training sessions 3 times a week for 12 weeks. The intensity of HIIT will be at 80% HR@VT2 measured in the first week and will increase to 90% in the second week. By week 3, the intensity will reach HR@VT2.
| Study group | Role | What they receive |
|---|---|---|
| aerobic training + muscle strength training | Experimental | 3 days/week -- 3-min warm up at 60% of HR@VT2 on a bike ergometer -- 6 x 1-min machine-base muscle strength exercises: leg press, chest press, knee extension, lat pull down, knee flexion, and shoulder raise -- 6 x 1-min high-intensity interval bouts at 80% HR@VT2 interspersed by 1-min active recovery will be performed. Receives: Behavioral: Exercise |
| aerobic training | Active comparator | 3 days/week -- 3-min warm up at 60% of HR@VT2 on a bike ergometer -- 2 blocks of 6 x 1-min high-intensity interval bouts at 70% HR@VT2 interspersed by 1-min active recovery Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of high-intensity interval training combined with muscle strength training
will be assessed from recruitment, adherence, compliance, safety, subjective exercise experiences and self-efficacy. Recruitment will be assessed by the proportion of patients remained interested and randomized after being informed of the requirements of the study; adherence will be assessed by the attendance to the prescribed exercise sessions; and compliance will be assessed by the proportion of participants adhering to prescribed exercise intensity. For safety, all mild, moderate, and severe symptoms and adverse events throughout this study will be recorded.
Measured: From recruitment to week-12
Secondary outcomes (5)
functional capacity
will be assessed using the Fullerton Functional Fitness Test, a valid and reliable measure of functional independence in older adults
Measured: From baseline to week-12
muscle function
Isometric strength, isokinetic muscle torque (i.e., strength) and fatigue will be measured using a dynamometer (CYBEX).
Measured: From baseline to week-12
cardiorespiratory fitness
will be measured by a gold-standard, symptom-limited CPET using metabolic equipment on an electronically braked cycle ergometer.
Measured: From baseline to week-12
muscle mass
will be measured using ultrasound at the mind-point of the thigh, from the greater trochanter to mid patella.
Measured: From baseline to week-12
QoL
will be assessed using Short Form 36 Health Survey Questionnaire (SF-36).
Measured: From baseline to week-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start1 Feb 2025
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older AdultStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tasuku Terada, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06825130
- Sponsor's protocol ID
- FMHS 34-1124
- Status last verified
- Feb 2025
- First submitted
- 3 Feb 2025
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Preliminary Efficacy of High-intensity Interval Training Combined with Muscle-strength Training in Older Women: Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06825130
- Acronym / sponsor ID
- FMHS 34-1124
- Conditions
- Older Adult
- Keywords
- Women, HIIT, Resistance exercise, Combined exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Women generally live longer than men but often experience a faster muscle mass loss due to inactivity, which can lead to weakness and disability. Despite these risks, women, particularly older women, are less active than men. In England, less than one-third of women engage in sufficient aerobic activity, and less than 5% do enough muscle strength training. Common reasons for not exercising include lack of time and enjoyment.
High-intensity interval training (HIIT) is an efficient and effective way to exercise that many women find more enjoyable than longer workouts. HIIT has been shown to be effective in older women, helping them improve their fitness with less time commitment. Because HIIT is time-efficient, it can be combined with muscle strength training without significantly increasing the duration of the exercise session, which may lead to even better fitness results.
This study will assess how practical it is for older women to do HIIT and strength exercise combined training. It will also investigate whether this combined approach can improve overall fitness, muscle strength, aerobic fitness, and quality of life more than HIIT alone.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aerobic training + muscle strength training | Experimental | Behavioral: Exercise3 days/week -- 3-min warm up at 60% of HR@VT2 on a bike ergometer -- 6 x 1-min machine-base muscle strength exercises: leg press, chest press, knee extension, lat pull down, knee flexion, and shoulder raise -- 6 x 1-min high-intensity interval bouts at 80% HR@VT2 interspersed by 1-min active recovery will be performed. |
| aerobic training | Active comparator | Behavioral: Exercise3 days/week -- 3-min warm up at 60% of HR@VT2 on a bike ergometer -- 2 blocks of 6 x 1-min high-intensity interval bouts at 70% HR@VT2 interspersed by 1-min active recovery |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Females (biologically at birth)
- At least 60 years of age at the time of signing the informed consent
- Non-smoker, including electronic cigarettes
- Not participating in routine high-intensity aerobic or muscle strength exercise training (≥ 75 min/week of structured vigorous aerobic exercise, or 2 times /week of structured muscle strength training)
- Able to perform a cardiopulmonary exercise testing (CPET) to exhaustion
Key exclusion criteria (4 listed)
- Diagnosed with cardiovascular disease, kidney disease, diabetes, obstructive pulmonary disease, or uncontrolled hypertension
- History or current neurological or psychiatric illness, or motor or cognitive restrictions
- Contraindications to symptom-limited cardiopulmonary exercise testing (CPET), including resting hypertension with systolic blood pressure >200 mmHg or diastolic blood pressure > 110 mmHg, uncorrected medical conditions, such as significant anemia, important electrolyte imbalance, and hyperthyroidism, mental impairment with limited ability to cooperate, physical disability that precludes safe and adequate testing.
- Having taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseParticipants will attend 30-min training sessions 3 times a week for 12 weeks. The intensity of HIIT will be at 80% HR@VT2 measured in the first week and will increase to 90% in the second week. By week 3, the intensity will reach HR@VT2. | Behavioural | aerobic training, aerobic training + muscle strength training |
Primary outcome
Feasibility of high-intensity interval training combined with muscle strength training
Time frame: From recruitment to week-12
will be assessed from recruitment, adherence, compliance, safety, subjective exercise experiences and self-efficacy. Recruitment will be assessed by the proportion of patients remained interested and randomized after being informed of the requirements of the study; adherence will be assessed by the attendance to the prescribed exercise sessions; and compliance will be assessed by the proportion of participants adhering to prescribed exercise intensity. For safety, all mild, moderate, and severe symptoms and adverse events throughout this study will be recorded.
5 secondary outcomes
functional capacity
Time frame: From baseline to week-12
muscle function
Time frame: From baseline to week-12
cardiorespiratory fitness
Time frame: From baseline to week-12
muscle mass
Time frame: From baseline to week-12
QoL
Time frame: From baseline to week-12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Older Adult, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tasuku Terada, PhD (441158230141, tasuku.terada@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of high-intensity interval training combined with muscle strength training (time frame: From recruitment to week-12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.